Nidek mark 5 nuvo lite инструкция

Mark 5 Nuvo® Lite Family

(Nuvo Lite and Nuvo Lite 3)

For models: 520, 525, 535, 920, 925, and 935

And serial numbers beginning 132-XXXXX

3949 Valley East Industrial Drive Birmingham, Alabama 35217 USA

Telephone: (205) 856-7200 • 24-Hour Fax: (205) 856-0533

Nidek Medical is a trademark of Nidek Medical Products, Inc. Mark 5 Nuvo® is a registered trademark of Nidek Medical Products, Inc

1.0 General Safety Warnings

This unit is not a life-support device. Geriatric, pediatric, or any other patient unable to communicate discomfort while using this device should receive additional monitoring.

This device supplies highly concentrated oxygen enriched product gas that promotes rapid burning.

DO NOT allow smoking or open flames within the same room of this device or the administration accessory (cannula).

Failure to observe this warning can result in severe fire, property damage, and / or cause physical injury or death.

Oxygen accelerates the combustion of flammable substances.

DO NOT use oil, grease, petroleum based or other flammable products on the device, the administration accessory (cannula) or the patient’s face / neck.

Only persons who have read and understood this entire manual should be allowed to service the device.

CONTRAINDICATIONS — Those who continue to smoke (because of the increased fire risk and the probability that the poorer prognosis by smoking will offset the treatment benefit).

Federal Law (US) restricts this device to sale by, or on the order of, a licensed

physician. This oxygen concentrator should be used only under the supervision

Only

of a licensed physician.

2.0 Glossary of Symbols

ON (Power switched on)

OFF (Power switched off)

Manufacturer Name and Address

Type B Device

Class II Protection

IPX1 Protection from vertically falling water drops

Do Not Expose to Open Flames

Do Not Expose to Oil or Grease

Tools Required / Technician Only

Refer to Technical Information / Service Manual

Refer to Instructions for Use / User’s Guide

Keep in Vertical Position

FRAGILE – Handle with Care

Visual Alarm Indicator

WARNING – A hazard or unsafe practice that can result in serious injury or death if conditions are not avoided.

Caution — A hazard or unsafe practice that can result in minor injury and / or property damage if conditions are not avoided.

Note – Information important enough to emphasize or repeat

Consult your equipment provider for further information regarding altitudes of 2200 m to 4000m (7500 to 13000ft).

The device should be stored in a dry area, with an ambient temperature between -20°C to 60°C (0°F to 140°F) at 1595% relative humidity. It must be stored, transported and used in the vertical position only.

Oxygen concentration can be affected after prolonged periods of storage – check device before use.

3.3 Alarms and Safety Features

Each device is equipped with indicator lights (green and yellow) and auditory indicators to identify various operational modes. Devices manufactured prior to 2018 were equipped with red and yellow indicator lights. The alarm modes are described below:

The device has an audible alarm to warn the user of problems. In order that the alarm may be heard, the maximum distance that the user can move away from it must be determined to suit the surrounding noise level.

If any of the below alarm conditions occur, press the Power Switch to the “O” (OFF) position. Refer to the Troubleshooting Guide in §5.2 for the possible cause and solution.

No voltage detection: In the event of a loss of mains power, an intermittent audible alarm is activated and the green light is no longer illuminated.

Oxygen Concentration Status Indicator: If supplied, in the event that the oxygen concentration falls below the set point percentage, a continuous audible alarm and the yellow indicator light will actuate. The oxygen concentration monitor is an electronic module capable of checking the effective oxygen concentration supplied by the concentrator. When the device is started, the green indicator light will flash until the concentration set point is reached (approximately two minutes).

A solid green indicator light means the power is applied to the concentrator and that it is ready to provide oxygen enriched air to the patient.

No special maintenance is required. The alarm set-point is factory set and the setting cannot be adjusted. All OCSI models are set at 85% ± 3%.

Blocked Cannula detection: If supplied, the device has a Blockage Alarm. A continuous audible alarm and both indicator lights will be lit immediately in the event the flow of oxygen to patient becomes blocked.

Malfunction detection: If low pressure occurs due to a mechanical failure, the indicator light will flash yellow and a continuous audible alarm will actuate.

Thermal safety: The compressor motor is protected by a thermal switch situated in the stator winding (145 ± 5° C). One tubeaxial fan cools the compressor compartment.

Electrical protection:

•A 5A circuit breaker is incorporated into the front cabinet of all 230V models

•A 10A circuit breaker is incorporated into the front cabinet of all 115V models

•Class II devices with insulated casings (EN60601-1 standard)

Safety valve: This is fitted on the compressor outlet and is calibrated to 3.4 bar (50 psig).

Fire Break: This device is fitted with a metal fire break at the Oxygen Product Outlet. This break will keep fire from entering the device.

3.4 Device Performance and Specifications

The performance of the device (especially the oxygen concentration) is quoted at 21°C (70°F) and one atmosphere. The specifications may change with temperature and altitude.

*Weight dependent on model and features

In compliance with EN ISO 80601-2-69, the flow supplied is equal to the flow set on the flowmeter, accurate to within ± 10% or 200 ml/min, whichever is greater.

The variation of the maximum recommended flow does not exceed ± 10 % of the indicated value when a back pressure of 6.9 kPa (1 psig) is applied to the output of the device.

Complies with EN 60529:2001 + A2:2014 rating of IPX1; enclosure protects internal electrical components against vertically falling water drops.

Complies with EN 60601-1:2006 [11.6.3]; enclosure protects internal electrical components against spilling of a glass of water (i.e. contents of humidifier).

4.0Service Provider (Home / Clinic / Hospital)

4.1Responsibilities

Service Providers of the Mark 5 Nuvo Lite Family (Nuvo Lite and Nuvo Lite 3) Oxygen Concentrators must assume responsibilities for handling, operational testing, patient instruction, and maintenance. These responsibilities are outlined below and throughout this manual.

To ensure patient safety, use only after one or more settings have been individually determined or prescribed for the patient at their specific activity levels – AND – only use the accessories that were used when the settings were determined.

While undergoing oxygen therapy, if the patient feels discomfort or experiences a medical emergency, seek medical assistance immediately.

As a Service Provider, you should do all of the following:

•Inspect the condition of each device immediately upon delivery to your location. Note any sign of damage, on the delivery receipt, and immediately report it directly to both the freight company and Nidek Medical Products, Inc.

•Ensure the operation of each device before delivery to a patient by completing the “Operational Check” provided in §4.2.

•Ensure each device has been thoroughly cleaned, the cabinet filter has been cleaned or replaced, and the nasal cannula and tubing has been replaced before delivering the device to a new patient or between patients.

•Deliver device only to patients authorized by a physician’s prescription. The device must not be used as a life-supporting or life sustaining device.

•Ensure a backup supply of oxygen is available.

•Instruct patients and patient caregivers how to use the device in conjunction with the Instructions for Use (PN 2010-8401CE), including required routine maintenance and cleaning of the device and filters. See “Patient / Caregiver Instruction” provided in §4.3.

•Record and notify Nidek Medical of any and all complaints provided by the patient or patient caregiver.

oThe FDA defines a complaint as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.”

•Be available to service each patient at any time.

•Keep service records of each device. A form approved by Nidek Medical has been provided in Appendix A.

•Repair components and replace parts only as outlined in this manual. Use only Nidek Medical parts for replacement. Refer to the Product Warranty Statement if parts replacement is required within the warranty period.

4.2Operational Check

Nidek Medical runs each device through a burn in period and tests every device thoroughly after manufacture before releasing it for shipment. As the Service Provider, it is your responsibility to perform the following check to ensure that the device is operational.

1.Plug in the power cord of the unit, following the electrical characteristics noted on the technical label, and set the Power Switch to the I (ON) position. The compressor should begin running.

2.Once the device has been running for approximately ten minutes, verify the concentration is within specifications, the flow is accurate and the alarms are operational. For units equipped with the Oxygen

Concentration Status Indicator (OCSI) (models 525, 535, 925, 935), the green indicator light will flash until the oxygen concentration reaches 85% ± 3% (approximately two minutes).

a.Verify oxygen concentration by:

i.Connect a calibrated oxygen concentration analyzer to the oxygen outlet.

1.If an oxygen humidifier bottle is used, remove it from the oxygen outlet. The concentration readings of the product gas after it has passed through a humidifier bottle will be erroneous and can result in damage to your analyzer.

2.Oxygen analyzers are available for purchase from Nidek Medical (see §5.4 for testing equipment part numbers).

ii.Set the flow rate of the device to the prescribed rate of the patient.

iii.Record oxygen concentration readings over a period of several minutes to reduce any cyclic variations. These readings should fall within the specifications provided in §3.4.

1.If not, refer to the troubleshooting chart in §5.2 for possible causes and solutions.

b.Verify the flow is accurate by:

i.Connect a calibrated flow gauge to the oxygen outlet.

1.If an oxygen humidifier bottle is used, remove it from the oxygen outlet.

2.Gauges are available for purchase from Nidek Medical (see §5.4 for testing equipment part numbers).

ii.Turn the flow knob clockwise until it stops (wide open).

iii.The reading should indicate 5 liters/min. (models 520, 525, 920 and 925) or 3 liters/min (models 535 and 935).

1.If not, refer to §5.3.11 for adjusting the regulator, or refer to the troubleshooting chart in §5.2 for other possible causes and solutions.

c.Verify alarms are operational by:

i.No Voltage Alarm

1.Unplug the power cord from the wall outlet.

2.Set the Power Switch to the I (ON) position.

3.This should immediately activate the intermittent audible alarm and there should be no indicator lights actuated.

a.If it does not, refer to the troubleshooting chart in §5.2 for possible causes and solutions.

ii.Blockage Alarm

1.Adjust the Flow Knob to desired flow rate.

2.Block the oxygen flow at the patient outlet

3.This should immediately activate a continuous audible alarm and both indicator lights should be actuated.

a.If it does not, refer to the troubleshooting chart in §5.2 for possible causes and solutions.

4.3 Patient / Caregiver Instruction

It is important that the patient and/or caregiver thoroughly understands how to operate their device. This enables proper treatment as prescribed by a qualified, licensed physician. You must explain that the purpose of this therapy is to alleviate symptoms. If the patient experiences any discomfort or the unit alarm sounds, they must notify their Service Provider and/or physician immediately. You, as the Service Provider, are responsible to see that each patient receives the Instructions for Use (IFU) (PN 2010-8401CE) and understands how to operate, clean and maintain their device.

•Refer to §4.2 in the IFU for the Start-Up procedure.

•Refer to §4.3 in the IFU for the Shut Down procedure.

•Refer to §5.1 in the IFU for the Cleaning procedures of the device itself, the filters and the accessories.

•Refer to §5.2 in the IFU for the Maintenance procedure.

Refer to §5.3.3 and §5.3.4 of this manual for instruction on replacing the inlet and final product filters.

5.0 Service Technicians

The design of the Mark 5 Nuvo Lite Family (Nuvo Lite and Nuvo Lite 3) allows for easy access and removal of most components. This allows you to perform scheduled maintenance, repair, and replacement of parts with minimal time and effort.

•Refer to §5.2 for the Troubleshooting Chart for a list of problems, possible causes and solutions.

•Keep service records of each device. A form approved by Nidek Medical has been provided in Appendix A.

•Repair components and replace parts only as outlined in this manual. Use only Nidek Medical parts for replacement.

•Refer to the Product Warranty Statement if parts replacement is required within the warranty period.

•Analyzers and gauges are available for purchase from Nidek Medical, see §5.4 for part numbers.

For your safety, be sure to set the Power Switch to O (OFF) position and unplug the power cord before you service the device.

5.1 Testing and Troubleshooting

Before reviewing the troubleshooting chart, the following questions may be useful to isolate any malfunctions.

1.Does the concentrator turn on when the switch is activated?

2.Are the filters clean?

3.Connect an oxygen analyzer to the outlet fitting of the device. Set the flow to 2LPM, is the concentration greater than 90%? Set the flow at 5 LPM (or 3LPM for models 535 and 935), is the concentration between 87 and 95.5%?

4.Connect test pressure gauge to the outlet fitting of the unit. Does the pressure read 7.1 psig (49 kPa) ± 20%?

5.Perform an air pressure test (P1). Does the pressure cycle between 10-15 and 25-32 psig approximately (70103 and 172-220 kPa)?

a.Remove the upper cabinet back (see §5.3.1 for instructions).

b.Remove the air supply tubing going to the control valve and install the test port tee fitting. (See Figures 5.1.1 and 5.1.2 below for Normal Operating Configuration and Test Port Configuration.)

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Mark 5 Nuvo Lite — кислородный концентратор премиум компакт-класса

Устройство Mark 5 Nuvo Lite из линейки товаров американского бренда Nidek оптимально подойдет для оксигенотерапии на дому. Благодаря данному прибору лечение кислородной недостаточности является максимально простым и удобным для пациента. Преимуществом данной модели является минимальный вес, составляющий всего 13,6 кг. Корпус устройства снабжен ручкой и колесами, поэтому его перемещение не представляет сложности даже для пациентов зрелого возраста или людей с ограниченной подвижностью.
Компактный прибор занимает мало места, поэтому Mark 5 Nuvo Lite без труда устанавливается не только в помещении, но и в салоне медицинского транспорта. Аппарат отличается простотой настройки, а уровень шума при работе не создает неудобств. При этом модель является очень производительной, благодаря чему может успешно использоваться для профилактического лечения и оказания срочной медицинской помощи.

Экономичность и легкость в обслуживании

Достоинством концентратора Mark 5 Nuvo Lite является простота сервисного обслуживания. При регулярном применении прибора замена фильтра предварительной очистки производится всего один раз в год.
В целях повышения эффективности кислородной терапии устройство оборудовано трехступенчатой системой фильтрации воздуха, благодаря чему происходит не только повышение содержания кислорода, но и бактериальная очистка воздуха.
Также Mark 5 Nuvo Lite снабжен диагностическим модулем для непрерывного контроля содержания кислорода. При изменении показателей срабатывает световой и звуковой индикатор.

Применение устройства

Концентратор кислорода «Марк 5 НУВО Лайт» компактный и высокопроизводительный прибор.
«Марк 5 Нуво Лайт» используется очень широко:

• Для организации лечения на дому с целью продолжительной кислородной терапии.
• В медицинских учреждениях, при проведении мер неотложной помощи.
• При проведении процедур профилактической кислородотерапии.
• Предназначен для длительной кислородотерапии на дому, в больничных и поликлинических условиях.
• Расходомер с регулятором потока кислорода от 0, 125 до 5 л/мин. (12 положений регулятора потока)
• При максимальном потоке 5 л/мин концентрация кислорода составляет более 90%.
• Круглосуточная работа в течение 24 часов.
• Звуковые предупреждения и оптические индикаторы.
• Счетчик проработанного времени (в часах).

В спортивных клубах и учреждениях санаторно-курортного типа прибор можно использовать для приготовления кислородных коктейлей.

ТЕХНИЧЕСКИЕ ХАРАКТЕРИСТИКИ Марк 5 НУВО Лайт

Ресурс	до 30 000 часов
Электропитание	220/230В ~50Гц 1,55А
Поток кислорода	от 0,125 до 5 литров в минуту (л/мин)
Концентрация кислорода в процентах	от 0,125 до 5 л/мин 90% (+6,5%/3%)
Максимальное давление кислорода на выходе	50,0 кПа (7,0 psig)
Подсчет проработанного времени	Счетчик времени (в часах)
Уровень шума	менее < 45 ДБ
Мощность	максимум 290 Вт
Принадлежности	Увлажнитель кислорода Канюля носовая с трубкой Маска кислородная с трубкой
Эксплуатация при температуре и влажности	от 5°С до 40°С, от 40% до 95%
Условия хранения Температура:	от 40°С до 70°С Влажность: от 10% до 100%
Вес Нетто	14,5 кг
Вес Брутто	16 кг
Упаковка Марк 5 нуво лайт	Картонная коробка с полиуретановыми вставками
Габаритные размеры	585 мм (в) х 360 мм (ш) х 230 мм (г)
Габаритные размеры упаковки	660 мм (в) х 480 мм (ш) х 340 мм (г)
Соответствие европейским директивам и стандартам	93/42 EEC, IEC606012, EN60601+A1+A2, ISO8359:1996, ISO9001: 2000/ISO13485:2003
Классификация устройства	класс II, тип B
Гарантия	3 года

Комплектация

Комплектация Nidek Марк 5 нуво лайт

Концентратор кислорода Nidek Mark 5 Nuvo Lite 1 шт

Удлинительная кислородная трубка 10 м. 1шт.

Маска кислородная 1шт.

Канюля кислородная, трубка 1.8м. 1 шт

Увлажнитель кислорода 1 шт

Фильтр грубой очистки 1 шт

Фильр тонкой очитки, оригинал для Mark 5 Nuvo Lite 1 шт

Инструкция по эксплуатации 1 шт

Гарантийный талон 1 шт

Документы

Инструкция по эксплуатации

Руководство по эксплуатации mark 5 nuvo lite инструкция

Техзадание

Техническое задание на Кислородный концентратор Mark 5 nuvo lite

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Комплект поставки:
Концентратор кислорода 1 шт.
Удлинительная кислородная трубка 10 м. 1шт.
Маска кислородная 1шт.
Канюля кислородная, трубка 1.8м. 1 шт.
Увлажнитель кислорода 1 шт.
Фильтр грубой очистки 1 шт.
Фильтр тонкой очитки 1 шт.
Инструкция по эксплуатации 1 шт.
Гарантийный талон 1 шт.

Наименование товара, товарный знак	Концентратор кислорода Mark 5 Nuvo Lite
Наименование страны происхождения товара	Соединенные Штаты Америки, ОКСМ: USA, 840
Описание требований	Наличие функции или величина параметра
Назначение	Для длительной кислородотерапии
Счетчик проработанного времени (в часах)	наличие
Звуковые предупреждения, оптические индикаторы	наличие
Оптические индикаторы	наличие
Уровень шума	37 Дб
Максимальное давление кислорода на выходе	50,0 кПа
Поток кислорода в диапазоне	от 0,125 л/мин до 5 л/мин (12 позиций переключателя)
Концентрация кислорода	90-95%
Электропитание	220В, 50Гц, 1,55А
Потребляемая электрическая мощность	290 Вт
Габаритные размеры	580 мм (высота) х 350 мм (ширина) х 220 мм (глубина)
Размеры в упаковке	660 мм (в) х 480 мм (ш) х 340 мм (г)
Масса, нетто	13,6 кг
Масса, брутто	16 кг
Упаковка	Картонная коробка
Колесики для передвижения	4 шт. вмонтированы в корпус
Классификация устройства	класс II, тип B
Гарантия производителя	3 года

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